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PrEPVacc

Status
Planned
Phase
IIb
Principal Investigator(s)
Prof. Pontiano Kaleebu
Objective

Three-arm, two-stage randomized Phase IIb trial testing two experimental vaccines and two options of oral PrEP. A total of 1668 participants, randomized as seen below.

Prevention Option(s)
HIV Vaccine
PrEP
Arms and Assigned Interventions
Description
First randomization to either (1) Experimental vaccine DNA-HIV-PT123+ AIDSVAX®/BE or (2) Experimental vaccineDNA-HIV-PT123+CN54gp140/MPLA and MVA-CMDR+CN54gp140/MPLA or (3) Placebo
Products
DNA
MVA
Protein
Description
Second randomization of the three arms to TAF/FTC (Descovy) or TDF/FTC (Truvada)
Products
TAF/FTC (Descovy)
TDF/FTC (Truvada)
Trial Sponsors
Sponsor: Imperial College London. Coordinating partners: P Kaleebu, E Ruzagira (MRC/UVRI & LSHTM, Uganda); J Weber/J Fox/C Kingsley (Imperial College, UK); S McCormack (UCL, UK); K Chinyenze (IAVI-Kenya); G Pantaleo/S Ding (CHUV/EVF, Switzerland)
January 2020
December 2022
Enrollment
1 668
Sites

MRC/UVRI Uganda Research Unit on AIDS

Masaka
Uganda

MRC HPRU

Durban
South Africa

MUHAS

Dar es Salaam
United Republic of Tanzania

MMRC

Mbeya
United Republic of Tanzania

INS/CISPOC

Maputo
Mozambique